EP3300679A1 - Ent-werkzeugantenne - Google Patents

Ent-werkzeugantenne Download PDF

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Publication number
EP3300679A1
EP3300679A1 EP17190800.7A EP17190800A EP3300679A1 EP 3300679 A1 EP3300679 A1 EP 3300679A1 EP 17190800 A EP17190800 A EP 17190800A EP 3300679 A1 EP3300679 A1 EP 3300679A1
Authority
EP
European Patent Office
Prior art keywords
conductive tube
signal
conductive
tube
coil
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
EP17190800.7A
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English (en)
French (fr)
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EP3300679B1 (de
Inventor
Vadim Gliner
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Biosense Webster Israel Ltd
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Biosense Webster Israel Ltd
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Publication date
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Publication of EP3300679A1 publication Critical patent/EP3300679A1/de
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/06—Devices, other than using radiation, for detecting or locating foreign bodies ; determining position of probes within or on the body of the patient
    • A61B5/061—Determining position of a probe within the body employing means separate from the probe, e.g. sensing internal probe position employing impedance electrodes on the surface of the body
    • A61B5/062—Determining position of a probe within the body employing means separate from the probe, e.g. sensing internal probe position employing impedance electrodes on the surface of the body using magnetic field
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A—HUMAN NECESSITIES
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    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/24—Surgical instruments, devices or methods, e.g. tourniquets for use in the oral cavity, larynx, bronchial passages or nose; Tongue scrapers
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    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1485—Probes or electrodes therefor having a short rigid shaft for accessing the inner body through natural openings
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    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/84—Drainage tubes; Aspiration tips
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    • A61B2017/00017—Electrical control of surgical instruments
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    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/1206—Generators therefor
    • A61B2018/1226—Generators therefor powered by a battery
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    • A61B90/36—Image-producing devices or illumination devices not otherwise provided for
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    • A61B90/36—Image-producing devices or illumination devices not otherwise provided for
    • A61B90/37—Surgical systems with images on a monitor during operation
    • A61B2090/376—Surgical systems with images on a monitor during operation using X-rays, e.g. fluoroscopy
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    • A61B90/36—Image-producing devices or illumination devices not otherwise provided for
    • A61B90/37—Surgical systems with images on a monitor during operation
    • A61B2090/376—Surgical systems with images on a monitor during operation using X-rays, e.g. fluoroscopy
    • A61B2090/3762—Surgical systems with images on a monitor during operation using X-rays, e.g. fluoroscopy using computed tomography systems [CT]
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    • A61B5/06—Devices, other than using radiation, for detecting or locating foreign bodies ; determining position of probes within or on the body of the patient
    • A61B5/065—Determining position of the probe employing exclusively positioning means located on or in the probe, e.g. using position sensors arranged on the probe
    • A61B5/066—Superposing sensor position on an image of the patient, e.g. obtained by ultrasound or x-ray imaging
    • A—HUMAN NECESSITIES
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    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A—HUMAN NECESSITIES
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    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/35—Communication
    • A61M2205/3576—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver
    • A61M2205/3592—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver using telemetric means, e.g. radio or optical transmission
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    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/50—General characteristics of the apparatus with microprocessors or computers
    • A61M2205/52—General characteristics of the apparatus with microprocessors or computers with memories providing a history of measured variating parameters of apparatus or patient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/82—Internal energy supply devices
    • A61M2205/8206—Internal energy supply devices battery-operated
    • A61M2205/8212—Internal energy supply devices battery-operated with means or measures taken for minimising energy consumption
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    • A61M2210/00—Anatomical parts of the body
    • A61M2210/06—Head
    • A61M2210/0681—Sinus (maxillaris)

Definitions

  • This invention relates generally to surgical tools, and specifically to a rigid surgical tool which is coupled wirelessly to a system controller.
  • Some surgical tools are stand-alone elements, not requiring additional connections such as cabling.
  • "smart" tools which measure parameters such as force exerted by the tool or the location and orientation of the tool, typically do require a connection to a system controller recording the parameters. While the connection may comprise cabling, the cabling may interfere with a physician's operation of the tool, so that a wireless connection may be preferable.
  • Another advantage of wireless connectivity is that there is substantially no limit to the number of wireless tools that may be deployed, whereas cable connections require connectors, thus limiting the number of non-wireless tools.
  • Wireless connections require an antenna to transmit and receive their electromagnetic energy, and an efficient antenna may be relatively large compared to the size of the tool, and especially compared to the size of the handle of such a tool.
  • An embodiment of the present invention provides apparatus, including:
  • the first conductive tube has a first electrical conductivity
  • the second conductive tube has a second electrical conductivity greater than the first electrical conductivity
  • the transceiver is fixedly installed within the handle.
  • the antenna has an antenna impedance
  • the apparatus further includes an impedance converter that is connected to the transceiver so as to receive the radiofrequency signal at a transceiver impedance and convert the radiofrequency signal to a converted radiofrequency signal at the antenna impedance, and the impedance converter is coupled to the second conductive tube so that the tube receives the converted radiofrequency signal and in response radiates the electromagnetic energy at the preset radiofrequency.
  • the impedance converter is fixedly installed within the handle.
  • the apparatus includes a magnetic radiator assembly that radiates the magnetic field traversing the insulated conductive coil, and a processor that receives the electromagnetic radiation from the antenna, and that analyzes the received radiation to determine a position of the insulated conductive coil with respect to the magnetic radiator assembly.
  • the apparatus includes circuitry which is configured to perform a Discrete Fourier Transform on the signal from the insulated conductive coil so as to generate a transformed signal, and the transceiver is connected to receive the transformed signal and to generate the radiofrequency signal in response to the transformed signal.
  • the orifice is a nostril of the human being, and the handle, the first conductive tube, the second conductive tube, the insulated conductive coil, and the transceiver are formed into an ear, nose, and throat (ENT) surgical tool that is inserted into the nostril.
  • ENT ear, nose, and throat
  • Embodiments of the present invention overcome the problem of requiring a relatively large antenna for an ENT wireless tool by having the "business end" of the tool, typically a rod, act both to perform its surgical function and as an antenna for radiofrequency radiation transmitted from, and received by, the tool.
  • the handle of the tool may be made diminutive and delicate, as is preferred by many ENT physicians.
  • a wireless surgical tool configured for an ENT procedure comprising suction from a sinus of a patient, comprises a handle to which is fixedly attached a biocompatible conductive tube.
  • the tube extends from the handle, and is configured to be inserted into an orifice of the patient, typically a nostril, for the ENT procedure.
  • a second conductive tube is fixed within the biocompatible conductive tube, so that the second tube is enclosed by the biocompatible conductive tube.
  • the two tubes together act as an antenna for electromagnetic radiation.
  • An insulated conductive coil is fashioned around, typically by winding, the second conductive tube so that it is fixed to the second conductive tube.
  • the coil generates a signal in response to a magnetic field traversing the coil.
  • the wireless surgical tool also comprises a transceiver, which is typically located within the handle.
  • the transceiver receives the signal from the insulated conductive coil, and in response generates a radiofrequency signal at a preset frequency, typically 2.4 GHz, and conveys the radiofrequency signal to the second conductive tube for radiation therefrom as electromagnetic energy at the preset frequency.
  • a wireless surgical tool 21 used in system 20 communicates wirelessly with a system processor 40, comprising a processing unit communicating with one or more memories, which operates the system.
  • system 20 is assumed to be used to perform a medical procedure, comprising a nasal sinus procedure on a patient 22, and, as is described in more detail below, tool 21 comprises one or more magnetic sensors 32 that are tracked during the procedure by a magnetic tracking system 23.
  • a CT computerized tomography
  • the CT image may typically comprise a magnetic resonance imaging (MRI) image or a fluoroscopic image
  • the image is assumed to comprise, by way of example, a fluoroscopic CT image
  • a magnetic radiator assembly 24 comprised in the magnetic tracking system, is positioned beneath the patient's head.
  • Assembly 24 comprises magnetic field radiators 26 which are fixed in position and which transmit alternating sinusoidal magnetic fields into a region 30 wherein the head of patient 22 is located.
  • radiators 26 of assembly 24 are arranged in an approximately horseshoe shape around the head of patient 22.
  • alternate configurations for the radiators of assembly 24 will be apparent to those having ordinary skill in the art, and all such configurations are assumed to be comprised within the scope of the present invention.
  • a distal tip of tool 21, having a magnetic sensor 32 at the tip is touched at different regions of the skin of patient 22.
  • the signals induced in the sensor in response to its interaction with the magnetic fields produced by assembly 24 enable the position of the tip to be tracked, once assembly 24 has been calibrated.
  • a probe handle 52, held by a physician 54 operating system 20, is connected to the proximal end of tool 21, the handle allowing the physician to manipulate the tool.
  • Flexible tubing 59 connects to handle 52, the tubing permitting the medical procedure referred to above, comprising drainage of fluid through a lumen of tool 21.
  • handle 52 may incorporate controls allowing the physician to control acquisition of the signals from the distal tip sensor, when the distal tip touches the skin.
  • the Carto® system produced by Biosense Webster, of Diamond Bar, CA, uses a system similar to that described herein for finding the location and orientation of a coil in a region irradiated by magnetic fields.
  • one or more other methods for registration known in the art, may be used to perform the registration.
  • System processor 40 may be mounted in a console 50, which comprises operating controls 58 that typically include a keypad and/or a pointing device such as a mouse or trackball.
  • Console 50 connects to the radiators via a cable and/or wirelessly.
  • Physician 54 uses operating controls 58 to interact with the processor while performing the ENT procedure using system 20. While performing the procedure, the processor may present results of the procedure on a screen 56.
  • Processor 40 uses software stored in a memory 42 to operate system 20.
  • the software may be downloaded to processor 40 in electronic form, over a network, for example, or it may, alternatively or additionally, be provided and/or stored on non-transitory tangible media, such as magnetic, optical, or electronic memory.
  • Processor 40 uses the software, inter alia, to operate magnetic radiators 26 of assembly 24.
  • the radiators transmit sinusoidal alternating magnetic fields of different frequencies into region 30, including the head of patient 22, and the fields from the radiators induce signals in sensors 32.
  • the signals, and/or data derived from the signals may be transmitted wirelessly to the processor which analyzes the received data and/or signals to derive location and orientation values, measured with respect to a frame of reference defined by the assembly, for the sensors.
  • FIGs. 2A, 2B, 2C, and 2D are schematic diagrams of ENT wireless tools, alternative to tool 21, that may be used in system 20, according to an embodiment of the present invention.
  • Fig. 2A illustrates an ENT tool 60, having a handle 60H fixedly connected to an inflexible tubular member 60M
  • Fig. 2B illustrates an ENT tool 62, having a handle 62H fixedly connected to an inflexible tubular member 62M
  • Fig. 2C illustrates an ENT tool 64, having a handle 64H fixedly connected to an inflexible tubular member 64M
  • Fig. 2D illustrates an ENT tool 66, having a handle 66H fixedly connected to an inflexible tubular member 66M.
  • Tools 60, 62, 64, and 66 are generally similar in shape to tool 21, all the tools having a handle fixedly connected to a tubular member. Tool 21 is described in more detail below, with reference to Figs. 3A and 3B .
  • Fig. 3A and Fig. 3B are respectively schematic diagrams of the exterior and interior of ENT wireless tool 21, according to an embodiment of the present invention.
  • a distal end of tool 21 comprises an external inflexible biocompatible metallic tube 70, typically formed from a poor electrical conductor such as titanium alloy or stainless steel.
  • Tube 70 acts as a protective shield that is fixed to an internal inflexible metallic tube 72 ( Fig. 3B , where tube 70 has been hidden), which is typically a good electrical conductor such as copper.
  • tube 72 together with tube 70 form a tubular member that acts as an antenna 71 of tool 21, so that antenna 71 is also referred to herein as tubular member 71.
  • member 71 may be inserted into an orifice of patient 22, such as a nostril of the patient.
  • Tube 70 is fixedly attached to a casing 74 (part of which is shown as transparent in Fig. 3B ) which encloses a printed circuit board (PCB) 76.
  • a tubular fluid connection 80 is also fixedly attached to casing 74, and, as shown in Fig. 3B , internal tube 72 couples to connection 80.
  • Connection 80 connects to tubing 59 ( Fig. 1 ) and is sealed to tube 72, so that during the ENT procedure body fluids may drain through internal tube 72 and connection 80 without leaking into casing 74.
  • Sensors 32 in the form of insulated coils of wire, are fashioned around tube 72, so that in the following description sensors 32 are also referred to herein as coils 32.
  • tool 21 is assumed to have three generally similar coils 32, one at the distal tip of tube 72, and two at more proximal locations on the tube.
  • other embodiments of the present invention may have more or less than three coils 32.
  • Each coil 32 is connected by a pair of insulated conductors 84 to PCB 76 which comprises low noise pre-amplifiers and an analog-to-digital (A/D) converter.
  • PCB 76 which comprises low noise pre-amplifiers and an analog-to-digital (A/D) converter.
  • a wireless sub-assembly 90 fixedly connects, via a water sealed connector 92, to casing 74.
  • Connector 92 is water sealed so that subsequent sterilization of tool 21 does not adversely affect components of tool 21.
  • Sub-assembly 90 is enclosed by a protective casing 94, which physician 54 is also able to use as handle 52, so that casing 94 is also referred to herein as handle 52.
  • handle 52 is typically configured to be as small as possible, and is also configured to be firmly grasped by the physician performing the procedure.
  • handle 52 contains a battery, and the size of the battery typically limits how small the handle can be made.
  • handle 52 has a cylindrical shape, with an approximate diameter of 2 cm and an approximate length of 3 cm.
  • Connector 92 has a plurality of conductors which transfer power to PCB 76, and which transfer clocking and data signals between the PCB and other circuitry 100 (described below) within sub-assembly 90.
  • the power and clocking signals are derived from power and clocking circuitry 98 (which is typically a PCB) which is driven by a battery 96.
  • Circuitry 98 also provides power and clocking signals to other elements of sub-assembly 90.
  • sub-assembly 90 also incorporates an accelerometer 97, which may be configured to turn off the power from battery 96 when tool 21 is not in use.
  • a signal processing board 102 comprising a field programmable gated array (FPGA) coupled to a processor, receives the digital signals from the A/D converter of PCB 76.
  • board 102 is formed from an FPGA module produced by Enclustra of Zurich, Switzerland.
  • the processor analyzes the signals to find the magnitudes of the magnetic fields traversing sensors 32, and the magnitudes are transferred to a transceiver board 104.
  • Transceiver board 104 is configured to transmit and receive at predetermined radiofrequencies, which, by way of example, are assumed to be in the 2.4 GHz band.
  • transceiver board 104 is formed from a CC2543 System-on-Chip produced by Texas Instruments of Dallas, Texas. Board 104 encodes the data received into its transmitting frequency, in preparation for wireless transmission to system processor 40.
  • Board 104 is coupled to antenna 71 by a balun 106 and a cable 108, the cable being galvanically connected to tube 72.
  • the balun acts as an impedance converter, so as to match the impedance of board 104 with the impedance of cable 108.
  • Cable 108 is typically coaxial, with an impedance of 50 ⁇ .
  • the balun also inherently acts as a filter for the 2.4 GHz band.
  • balun 106 comprises a 2450BM15 balun produced by Johanson Technology Inc. of Camarillo California.
  • components that operate at frequencies of the order of 2.4 GHz typically operate according to a distributed element model, having capacitive, inductive, and resistive properties. This contrasts with the operation of components at lower frequencies, which typically operate according to a lumped element model, having either capacitive or inductive or resistive properties.
  • components of tool 21 prior to transceiver board 104 may typically be considered as lumped components, while components of the board, and subsequent components such as cable 108 and antenna 71, typically operate in a distributed fashion.
  • tubes 70 and 72 act as antenna 71, and in embodiments of the present invention the antenna receives from board 104, and transmits to the board, radiofrequency signals at the predetermined radiofrequencies of board 104.
  • antenna 71 transmits electromagnetic radiation from the antenna, and receives electromagnetic radiation at the antenna.
  • antenna 71 may be considered to operate as a monopole antenna, being resonant at any odd number of quarter wavelengths.
  • antenna 71 i.e., tubes 70 and 72, may be formed to be any odd number of approximately 3 cm lengths.
  • actual values of the length of the tubular member may differ from the theoretical values.
  • antenna 71 is formed to be approximately 15 cm long, and the inventors have found that using this length the antenna, i.e. tubular member 71, resonates with a relatively high Q.
  • the Q is reduced because antenna 71 has an external tube 70 formed from material having a relatively poor electrical conductivity, and the diminution of Q makes selection of a resonant length of the antenna easier. Consequently, those having ordinary skill in the art will be able to select other lengths than 15 cm for antenna 71 without undue experimentation.
  • Fig. 4 is a schematic block diagram of an ENT wireless tool, according to an embodiment of the present invention. While, for clarity, the following explanation of the block diagram is directed to tool 21, it will be understood that the block diagram, mutatis mutandis, applies to other ENT wireless tools described herein.
  • a sensors block 150 corresponds to sensors 32, the sensors being physically located on tube 72 of antenna 21. Signals from sensors block 150 are fed to a signal processing block 152, which comprises boards 76 and 102. Data from the signal processing block is fed to a transceiver block 154, corresponding to transceiver board 104, and encoded data from the board is fed, via a balun and filter block 156, comprising balun 106, to antenna 71.
  • a broken line 158 signifies that sensors 32 and antenna 71 are physically at the same location, tube 72.
  • Antenna 71 radiates electromagnetic radiation, conveying the signals from sensors 32 and/or data derived from the signals, to processor 40.
  • the data derived from the signals is converted in signal processing block 152, i.e., boards 76 and 102, using a Fourier Transform, typically a Discrete Fourier Transform (DFT), and the DFT is transmitted from antenna 71.
  • a Fourier Transform typically a Discrete Fourier Transform (DFT)
  • DFT Discrete Fourier Transform
  • the electromagnetic radiation may also be used to convey other operating parameters of tool 21, such as a timestamp, a state of battery 96, and/or values derived from other elements that may be incorporated into the tool, for example, accelerometer 97, to the processor.
  • Processor 40 may also be configured to convey, via electromagnetic radiation received by antenna 71, control signals from the processor for tool 21.
  • tube 72 has multiple functions: acting as an antenna for tool 21, retaining location tracking sensors for the tool, and performing the surgical functions of the tool.
EP17190800.7A 2016-09-14 2017-09-13 Ent-werkzeugantenne Active EP3300679B1 (de)

Applications Claiming Priority (2)

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US201662394426P 2016-09-14 2016-09-14
US15/676,579 US11058446B2 (en) 2016-09-14 2017-08-14 ENT tool antenna

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CA (1) CA2979159A1 (de)
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AU2017225009A1 (en) 2018-03-29
CN107822709A (zh) 2018-03-23
CA2979159A1 (en) 2018-03-14
US11058446B2 (en) 2021-07-13
CN107822709B (zh) 2022-04-22
ES2764704T3 (es) 2020-06-04
IL254352A0 (en) 2017-11-30
IL254352B (en) 2021-01-31
EP3300679B1 (de) 2019-10-23
JP7046536B2 (ja) 2022-04-04
JP2018043009A (ja) 2018-03-22
US20180070969A1 (en) 2018-03-15

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